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Quality Control Project

Location:
Philadelphia, PA
Posted:
January 02, 2014

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Resume:

Chanae Rodgers

267-***-****

Email: acbycn@r.postjobfree.com

PROFILE:

To secure and maintain a part-time or full-time position utilizing my

Bachelor Degree in Life Science.

PROFESSIONAL EXPERIENCE:

MERCK

Quality Specialist I

Feb 2013 - Current

. Provides direct quality support to the production area

. Ensures product/process quality to facilitate product release

. Audit of process documents and log books to ensure accuracy and

completeness

. Ensure all processes are performed according to cGMP, GLP, GCP and

follows FDA regulations

GLAXOSMITHKLINE Oct 2012 - Feb

2013

Documentation Specialist

. Obtain, track and edit project specific data within GSK quality

systems.

. Support all training activities utilizing the GSK learning management

system

. Complete Document Compliance Quality Check on Controlled documents

. Ensure documents comply with SOPs and cGMP

. Write, review, edit and execute protocols and procedures.

TEVA PHARMACEUTICALS Feb 2012 - Oct

2012

Quality / Associate Scientist I

. Perform analytical testing of finished dosage pharmaceutical products

and raw materials, following analytical methodology.

. Assist with data audits of standards, reagents, and other analytical

instrumentation.

. Assist in ensuring testing is in adherence to schedules

. Maintain accurate, detailed records of work performed using LIMS or

other data collection

. Follows cGMP and cGLP requirements

. Read and interpret USP and laboratory methodology

BIOCLINICA Apr 2011- Feb 2012

Study Quality Control Representative

. Conduct protocol/project specific testing, software testing, UAT

. Document Forms and eCRF Design QC

. Document edit checks and protocol specific QC

. Conduct quality review of reports, data listings, individual patient

profiles, SAS Exports and data migration activities.

. Reading, understanding and adhering to SOPs

MEDIMMUNE Jun 2010 - Aug 2010

Manufacturing Technician

. Aid with the manufacturing of H1N1 vaccines.

. Quality control: test/inspect vaccines for contaminates.

. Worked in controlled and non-controlled areas, demonstrate aseptic

techniques.

. Complete documentation to comply with FDA and GCP/GMP/GLP regulations

. Review batch record/ LIMS system

. Disposed of bio-chemical materials

ALLIANCE HEALTHCARE INFORMATION, LLC Aug 2009 - Jun 2010

Counselor Communicator/ Quality Control

. Enroll participants into clinical trials.

. Counsel participants about the medications and/or products of their

interest, within a call center setting inbound/outbound calls.

. Complete documentation to comply with FDA and GCP/GMP/GLP regulations

. Documented and reported Adverse Events.

. Follow SOPs

VALLEY YOUTH HOUSE Apr 2007- Feb 2010

Childcare Worker

. Help youth in need of guidance

. Protect and assure safety of all residents

. Counsel youth / document progress

Staffing Plus- Philadelphia, PA Apr 2006 -

Dec 2007

Residential Work/TSS

. Provided care for mentally and physically disabled clients

. Document daily progress of each individual

. Counsel each client to express greatest potential

Education:

PENN STATE UNIVERSITY- Abington, PA

Bachelors in Life Science

RELEVANT COURSES

Biology, Chemistry, Biochemistry, Microbiology, Animal Biology, Animal

Behavior, Organic Chemistry, Pathology



Contact this candidate